New Parkinson's drug shows promise in early safety trial
NCT ID NCT04867642
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tested a new drug called UCB0022 in 100 healthy volunteers and people with Parkinson's disease. The main goal was to check if the drug is safe and how the body processes it. This is an early-stage trial, so it does not prove the drug works for Parkinson's symptoms yet.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
-
Phase 1
The first testing in people. Mainly checks safety and dose, usually in a small group.
- Participants
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100 people
The number who actually took part.
- Started
-
Apr 2021
- Finished
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Feb 2023
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
-
18 to 75 years
- Sex
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Anyone
- Healthy volunteers
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Accepted
You do not need to have the condition being studied to take part.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * Participant must be 18 to 55 years of age inclusive or 35 to 75 years for part C, at the time of signing the informed consent * Participants who are overtly healthy as determined by medical evaluation including medical history, physical examination, laboratory tests, and cardiac monitoring * Study participant has a blood pressure (BP) and heart rate (HR) before the first dose, as determined by triplicate BP/HR measurements in a supine position, of mean systolic BP ranging between 90 and 130 millimeters of mercury (mmHg), mean diastolic BP ranging between 50 and 80 mmHg, and mean HR between 45 and 90 beats per minute (bpm) * Participant has a body weight of at least 45 kg and body mass index (BMI) within the range 18 to 30 kg/m\^2 (inclusive) * Participants are male or female: * A male participant must agree to use contraception as detailed in the protocol during the treatment period and for at least 7 days after the last dose of study treatment and refrain from donating sperm during this period * A female participant is eligible to participate if she is not pregnant, not breastfeeding, and at least 1 of the following conditions applies: Not a woman of childbearing potential (WOCBP) as defined in the protocol OR A WOCBP who agrees to follow the contraceptive guidance in the protocol during the Treatment Period and for at least 90 days after the last dose of study treatment Part C only: * Patient must have a documented history of idiopathic Parkinson's disease confirmed by a neurologist, and with no other atypical or secondary parkinsonism (eg, multiple-system atrophy, progressive supranuclear palsy, or evidence of drug-induced parkinsonism) * Participants with Hoehn and Yahr Stages of 1 to 3 inclusive, (Hoehn and Yahr, 1967) at Screening when in the ON state * Participants on stable dosage of all anti-Parkinsonian therapy for at least 30 days prior to first investigational medicinal product (IMP) administration (with the exception that MAO-B inhibitors that must be maintained at a stable level for at least 8 weeks prior), and it is anticipated that no changes will be needed during the course of the study * Participant has a BP and HR at Screening, as determined by triplicate BP/HR measurements in a supine position, of mean systolic BP ranging between 90 and 140 mmHg, mean diastolic BP ranging between 50 and 90 mmHg, and a mean HR between 50 and 90 bpm Exclusion Criteria: * Participant has history or presence of cerebro/cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrinological, hematological, psychiatric or neurological disorders capable of significantly altering the absorption, metabolism, or elimination of drugs; constituting a risk when taking the study intervention; or interfering with the interpretation of data * Participant has a high risk for cardiovascular accident based on family history or on laboratory test * Participants with hypertension requiring medical treatment within 6 months before the Screening, or with clinically significant orthostatic hypotension * Participant has a known hypersensitivity to any components of the study medication or comparative drugs (and/or an investigational device) as stated in this protocol * Participant has a history of unexplained syncope or a family history of sudden death due to long QT syndrome * Participant has active neoplastic disease or history within the past 5 years of screening visit except for basal cell or squamous epithelial carcinomas of the skin that have been treated with SOC. Study participant has a history of a major organ transplant or hematopoietic stem cell/marrow transplant * Participant has past or intended use of over-the-counter or prescription medication including herbal medications within 2 weeks or 5 half-lives prior to dosing * Participant has used hepatic enzyme-inducing drugs within 2 months prior to dosing * Participant has alanine transaminase (ALT), aspartate aminotransferase (AST), or alkaline phosphatase (ALP) \>1.0x upper limit of normal (ULN) * Participant has current or chronic history of liver disease or known hepatic or biliary abnormalities (with the exception of Gilbert's syndrome or asymptomatic gallstones) * Participant has a current history of alcohol or drug use disorder within the last Y Statistical Manual of Mental Disorders Version 5 (DSM-5), within the last year * Participant has any clinically relevant electrocardiogram (ECG) finding at the Screening Visit or at Baseline * Participant has the presence of hepatitis B surface antigen (HBsAg) at Screening or within 3 months prior to dosing * Participant has a positive hepatitis C antibody test result at Screening or within 3 months prior to starting study intervention * Participant has a positive human immunodeficiency virus (HIV) antibody test * Participant has clinical signs and symptoms consistent with COVID-19 or had a positive Sars-Cov-2 test result within the last 4 weeks prior to dosing * Active treatment or a history of glaucoma Part C only: * Participant with implantable intracranial stimulator or history of intracranial surgery * Participant with documented diagnosis of dementia or a Montreal Cognitive Assessment (MoCA) score \<26 at screening * Participant with history of psychotic symptoms (including significant hallucinations) requiring treatment with an antipsychotic medication within the 12 months prior to Admission
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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UP0091 1
London, United Kingdom
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Other studies related to the condition(s) this trial covers.
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